UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection
Title of the study (Brief title)	Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection
Region	Japan

Condition
Condition	Postoperative persistent air leak or postoperative pneumothorax after pulmonary resection
Classification by specialty	Chest surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Treatment for postoperative persistent air leak or postoperative pneumothorax is drainage, pleudolesis or operation. In Japan OK-432 has been used as pleurodesis routinely, however anaphylaxis and acute exacerbation of interstitial pneumonia has been reported as the adverse events. Otherwise the indication for the pleurodesis with OK-432 is for malignant pleural effusion. The drug price is about 7,000 yen and so expensive. Therefore safe and low-cost drug is expected. Pleurodesis with a 50% glucose solution has been reported for several years. The treatment cause hyperglycemia, however it has been reported as the safe and low-cost treatment. On the other hand there is no prospective study about the effect and adverse events and we planed this study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Rate of stopping air leakage after pleurodesis with a 50% glucose solution
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	50% glucose solution group
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Postoperative persistent air leak or postoperative pneumothorax after pulmonary resection
Key exclusion criteria	1) Patients with poor general condition caused by disease such as severe infection 2) Pregnant, breastfeeding , sexually active woman, or patients with no contraception. 3) Patients with severe diabetes mellitus 4) Patients registration to this study is deemed difficult due to mental disorders clinically relevant 5) Considered to be inappropriate for the participation in this study by the investigators 6) Patients unwilling to sign the consent form for participation
Target sample size	26

Research contact person
Name of lead principal investigator	Yasushi Mizukami
Organization	Hokkaido Cancer Center
Division name	Department of thoracic surgery
Address	2-3-54, Kikusui 4-jo, Shiroishi-ku Sapporo-shi, Hokkaido, 003-0804, Japan
TEL	011-811-9111
Email	mizukami@sap-cc.go.jp

Public contact
Name of contact person	Yasushi Mizukami
Organization	Hokkaido Cancer Center
Division name	Department of thoracic surgery
Address	2-3-54, Kikusui 4-jo, Shiroishi-ku Sapporo-shi, Hokkaido, 003-0804, Japan
TEL	011-811-9111
Homepage URL
Email	mizukami@sap-cc.go.jp

Sponsor
Institute	Hokkaido Cancer Center
Institute
Department

Funding Source
Organization	Hokkaido Cancer Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 24 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 10 Month 14 Day
Anticipated trial start date	2016 Year 10 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 24 Day
Last modified on	2017 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028751